An Early Phase 1 interventional study of Huafu Shengji Ointment and ethacridine lactate solution in Diabetic Foot, sponsored by Beijing Daxing District Hospital of Integrated Chinese and Western Medicine. Not yet recruiting. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Beijing Daxing District Hospital of Integrated Chinese and Western Medicine · Early Phase 1, Interventional, and Treatment
Diabetic foot ulcers, as a complication of diabetes with high disability and mortality rates, have become a significant global healthcare burden and medical challenge worldwide. The clinical situation of chronic non-healing ulcers leading to repeated amputations has not yet been resolved. In preliminary clinical practice, Huafu Shengji Ointment has been shown to significantly improve the complete healing rate of ulcer wounds. This study aims to further comprehensively evaluate the therapeutic effects of Huafu Shengji Ointment and provide high-quality evidence.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Beijing Daxing District Hospital of Integrated Chinese and Western Medicine is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Patients who meet the following criteria will be included:
Exclusion Criteria:
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Patients who meet any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After debridement, Huafu Shengji Ointment is applied topically with a coverage thickness of 1mm, followed by sterile gauze dressing. The dressing is changed every other day. The treatment period is 4-8 weeks.
Drug: Huafu Shengji Ointment
After debridement, the wound is cleaned and disinfected with ethacridine lactate solution, then covered and dressed with sterile gauze. The dressing is changed every other day. The treatment period is 4-8 weeks.
Drug: ethacridine lactate solution
Huafu Shengji Ointment 1. The experimental group received conventional medical treatment: diabetes-related knowledge education, blood sugar control, blood pressure reduction, blood lipid regulation, antiplatelet drugs, vasodilation, nerve nutrition, and the use of antibiotics. 2. The experimental group receive local debridement: iodophor disinfection, saline cleaning, removal of necrotic tissue, and wound exposure. 3. After debridement, Huafu Shengji Ointment is applied topically with a coverage thickness of 1mm, followed by sterile gauze dressing. The dressing is changed every other day. The treatment period is 4-8 weeks.
ethacridine lactate solution 1. The control group received conventional medical treatment: diabetes-related knowledge education, blood sugar control, blood pressure reduction, blood lipid regulation, antiplatelet drugs, vasodilation, nerve nutrition, and the use of antibiotics. 2. The control group receive local debridement: iodophor disinfection, saline cleaning, removal of necrotic tissue, and wound exposure. 3. After debridement, the wound is cleaned and disinfected with ethacridine lactate solution, then covered and dressed with sterile gauze. The dressing is changed every other day. The treatment period is 4-8 weeks.
ulcer area
Method of measuring ulcer area: Sterile transparent dressings are used to trace the edges of the ulcer, digital cameras are used to capture the images, and ImageJ is utilized for analysis and processing.
Time frame: Measured once a week, for a total of 8 weeks.
granulation tissue coverage
Granulation tissue area coverage rate = (Area of the wound covered by granulation tissue \[mm\^2\]) / (Total wound area \[mm\^2\]) × 100%
Time frame: Measured once a week, for a total of 8 weeks.
ulcer volume
Ulcer volume measurement method: After debridement is completed, the wound surface is dried with a dry cotton ball. Sterile saline is injected into the ulcer cavity using a sterilized syringe until the liquid level is flush with the skin. When the ulcer is a fistula, one end of the fistula is sealed with sterile transparent film, and then saline is injected. The volume of the injected saline is equivalent to the volume of the ulcer.
Time frame: Measured once a week, for a total of 8 weeks.
the time of complete wound healing
Digital cameras capture images, documenting the process of wound from the ulcerative state to the complete in situ healing of the skin tissue.
Time frame: complete wound healing (assessed up to 8 weeks)
the skin temperature around the wound
0 Normal 1. Intermittently feels cold 2. Persistently cold, but can be relieved with warming measures 3. Persistently cold, and cannot be relieved with warming measures 4. Even with stronger warming measures than usual in a 20°C environment, still feels cold.
Time frame: Measured once a week, for a total of 8 weeks.
the degree of pain
0 No pain 1. Pain occurs with activity or exertion 2. Intermittent pain at rest 3. Persistent pain at rest, but tolerable 4. Severe persistent pain, sleepless nights, and pain relief requires analgesics
Time frame: Measured once a week, for a total of 8 weeks.
skin color
0 Normal skin color 1. Intermittently pale skin 2. Persistently pale skin 3. Skin appears purplish-cyanotic 4. Skin appears purplish-black or black
Time frame: Measured once a week, for a total of 8 weeks.
the extent of wound exudate
Covered with a 10 cm × 10 cm single-layer sterile gauze, scored based on the number of layers of gauze soaked through by exudate over 24 hours 0 1 layer 1. 2 layers 2. 3 layers 3. 4 layers 4. ≥ 5 layers
Time frame: Measured once a week, for a total of 8 weeks.
alanine aminotransferase
The reference range is 0-40 U/L.
Time frame: Measured once a week, for a total of 8 weeks.
aspartate aminotransferase
The reference range is 0-40 U/L.
Time frame: Measured once a week, for a total of 8 weeks.
urea nitrogen
Reference range value 3.2-7.1 mmol/L
Time frame: Measured once a week, for a total of 8 weeks.
serum creatinine
Reference range value: Males 53-106 μmol/L, Females 44-97 μmol/L
Time frame: Measured once a week, for a total of 8 weeks.
electrocardiogram
During the study period, the P wave, P-R interval, QRS complex, and QT interval of the electrocardiogram will be assessed.
Time frame: Measured once a week, for a total of 8 weeks.
No study locations are listed for this record.
Start is estimated for Sep 2024; primary completion for Dec 2025, 15 months later.
Of 26 phase 1 interventional studies under Diabetic Foot, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 43. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Beijing Daxing District Hospital of Integrated Chinese and Western Medicine